Low-profile vascular closure systems and methods of using same

Abstract

A closure device for an arteriotomy includes an elongate tube having a distal opening, a staple disposed within the tube, and a frangible cap mounted across the distal opening to guard the staple tips against contact with the tissue track. The frangible cap is pierced, fractured or torn when the staple is advanced through the distal opening. A portion of the torn frangible cap may be implanted with the staple as a pledget. The staple may be carried within the elongate tube by a stapler comprising an elongate hollow shaft and an elongate driver slidably disposed therein. A pair of opposing actuation tips is disposed at a distal end of the hollow shaft to define an open-sided staple chamber there between. An anvil is fixedly disposed within the staple chamber, which holds at least a proximal portion of the staple.

1. A closure device for an arteriotomy comprising:
 an elongate tube having a distal opening; 
 a staple being slidably disposed within the tube; and 
 a frangible cap fixed to the elongate tube and mounted across the distal opening, wherein the frangible cap is configured to be pierced, fractured, or torn when the staple is advanced through the distal opening and the frangible cap such that at least a portion of the frangible cap is configured to remain fixed to the elongate tube after the staple is advanced through the distal opening. 
 
   
   
     2. The closure device of  claim 1 , wherein the frangible cap comprises a biocompatible material selected from the group consisting of metallic foil, polyurethane, polyester or polystyrene, natural or synthetic rubber, butadiene/acrylonitrile copolymers, copolyesters, ethylene vinylacetate (EVA) polymers, ethylene/acrylic copolymers, ethylene/propylene copolymers, fluorosilicone, latex, polyalkylacrylate polymers, polybutadiene, polybutylene, polyethylene, polyisobutylene, polyisoprene, polyurethane, silicone, styrenebutadiene copolymers, styrene-ethylene/butylene-styrene, thermoset elastomer, thermoplastic elastomer and combinations thereof. 
   
   
     3. The closure device of  claim 1 , wherein the frangible cap includes perforations, grooves or disruptions that define tear lines within the cap. 
   
   
     4. The closure device of  claim 1 , wherein the frangible cap is configured to be torn into a configuration having one or more deflectable sections that move aside as the staple is advanced through the distal opening and the frangible cap. 
   
   
     5. The closure device of  claim 1 , wherein the frangible cap is configured to be torn into a configuration having a pledget separated from a remainder of the frangible cap that remains fixed to the elongate tube, the pledget being retainable with the staple. 
   
   
     6. The closure device of  claim 5 , wherein the pledget includes a physiologically active agent selected from the group consisting of Cefazolin, chlorhexidine, collagen or derivatives thereof, fusidic acid, heparin, Novobiocin, phosphorylcholine, polymyxin B, rifampicin, silver or a silver compound, and tetracycline. 
   
   
     7. The closure device of  claim 1  wherein the elongate tube further comprises at least two opposing longitudinal slots extending proximally from the distal opening, the staple being disposed within the tube and having at least two opposing legs aligned with the at least two slots. 
   
   
     8. The closure device of  claim 7  further comprising an elongate stapler slidably disposed within the elongate tube, the stapler comprising:
 an elongate hollow shaft and an elongate driver slidably disposed therein; 
 a pair of opposing actuation tips disposed at a distal end of the shaft and defining an open-sided staple chamber there between, the open sides of the chamber being aligned with the at least two slots in the elongate tube; and 
 an anvil disposed within the staple chamber and affixed to one of the actuation tips; 
 wherein at least a proximal portion of the staple is held within the staple chamber. 
 
   
   
     9. The closure device of  claim 1  wherein the elongate tube includes at least two side tubes for riding along a pair of stabilization wire guides, the side tubes being coupled parallel to, and disposed on opposing sides of a distal portion the elongate tube. 
   
   
     10. The closure device of  claim 1  further comprising an elongate stapler slidably disposed within the elongate tube and holding at least a proximal portion of the staple. 
   
   
     11. The closure device of  claim 10  wherein the stapler comprises:
 an elongate hollow shaft and an elongate driver slidably disposed therein; 
 a pair of opposing actuation tips disposed at a distal end of the shaft and defining a staple chamber there between; and 
 an anvil disposed within the staple chamber and affixed to one of the actuation tips; 
 wherein at least a proximal portion of the staple is held within the staple chamber.